Sr. Specialist, 880 Non Sterile Safety & Quality Compliance Operations (Onsite)
$117,000–$184,200 year
On-siteRahway, New Jersey, United States
Job Summary
Champion a strong safety culture and ensure adherence to site, corporate, and regulatory safety requirements within Building 880 FLEx Non-Sterile Operations. Lead and support deviations, investigations, CAPAs, change controls, and risk assessments while driving sustained audit and inspection readiness through routine compliance monitoring. Oversee SOP lifecycle management, develop or update procedures, and monitor training status to ensure workforce readiness. Analyze safety and quality metrics to identify trends, applying Lean and root cause problem-solving tools to improve operational performance and compliance outcomes. Partner with Production, Engineering, and Quality teams to resolve compliance risks and prevent recurrence.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Chemistry, or related discipline
- 4+ years of pharmaceutical or GMP manufacturing experience
- Experience with investigations, CAPAs, audits, and quality systems
- Strong knowledge of cGMPs, compliance requirements, and safety programs
- Strong communication, problem-solving, and cross-functional collaboration skills
- Excellent verbal and written communication skills, including presentation skills
- Demonstrated ability to manage projects and priorities to meet deliverables and timelines
- Strong attention to detail, flexibility, and awareness of production and associated quality issues
- Ability to work in a dynamic environment with rapidly changing needs
- Ability to work across functions and sites, and with all levels of staff and management
- Valid Driving License
Desired Qualifications
- Experience in drug product manufacture/testing
- Oral drug product knowledge and experience
- Knowledge of R&D or clinical supply areas and processes
- Experience with manufacturing investigations and CAPAs
- System knowledge of Veeva and SAP
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